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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIV)

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PGL4001 5 mg
PGL4001 10 mg
Sponsored by
PregLem SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Be a pre-menopausal woman between 18 and 50 years inclusive.
  • Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
  • Have FSH levels ≤ 20 mIU/mL
  • Have excessive uterine bleeding due to myoma.
  • Have regular menstrual cycles
  • Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.
  • If of childbearing potential the subject must be practicing a non-hormonal method of contraception.

Exclusion Criteria:

  • Has a history of or current uterine, cervical, ovarian or breast cancer.
  • Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
  • Has a known severe coagulation disorder.
  • Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM).
  • Has abnormal hepatic function at study entry.
  • Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study.
  • Has a current (within twelve months) problem with alcohol or drug abuse.
  • Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.

Sites / Locations

  • Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
  • UZ Leuven Campus Gasthuisberg
  • CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique
  • CHU Mont-Godinne
  • Centrum ambulantni gynekologie a primarni pece
  • FN Brno Gynekologicko - porodnická klinika
  • Sanatorium SANUS
  • Nemocnice Jihlava Gynekologicko - porodnicke oddeleni
  • G-CENTRUM Olomouc s.r.o.
  • FN Olomouc, Porodnicko-Gynekologicka klinika
  • Femina Sana, s.r.o.
  • Hôpital Bicêtre - APHP
  • Hôpital Bichat, Service de Gynécologie Obstétrique
  • CHU Bretonneau Service de Gynécologie Obstétrique
  • Private practice
  • Private practice
  • Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe
  • Frauenarztpraxis
  • Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung
  • Technische Universität München
  • Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly
  • Institution Robert Karoly Maganklinika
  • Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo
  • Josa Andras Oktatokorhaz
  • Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly
  • Szuleszeti es Nogyogyaszati Osztaly
  • Sandor Dent Bt.
  • Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"
  • Policlinico Universitario "Agostino Gemelli"
  • Riga 1. hospital
  • Latvian Medical Marine Center
  • Medical Company "ARS"
  • Saules Family Medicine Center
  • Family Medicine Centre"Seimos Gydytojas"
  • Private Clinic "Maxmeda"
  • Private Clinic "Kardiolita"
  • Centrul Medical SANA SRL
  • Quantum Medical Center SRL Obstetrica-Ginecologie
  • Fortis Medical Center SRL Obstetrica Ginecologie
  • Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie
  • Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie
  • Spitalul Clinic de Obstetrica
  • Kharkiv City Perinatal Center Gynaecological Department #1
  • Municipal Institution "Maternity Hospital #1" City Center of family planning
  • Maternity Hospital#4 Department of Gynaecology
  • MRC Centre for Reproductive Health University of Edinburgh
  • North Middlesex University Hospital NHS Trust
  • Women's Health, Royal Victoria Infirmary
  • Norfolk & Norwich University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ulipristal acetate (PGL4001) 5mg

Ulipristal acetate (PGL4001) 10mg

Arm Description

All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.

All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.

Outcomes

Primary Outcome Measures

Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses
Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.

Secondary Outcome Measures

Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4
Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.
Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses
Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.
Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids
For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses.
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)
Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses.
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)
Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses.
Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)
Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses.

Full Information

First Posted
June 19, 2012
Last Updated
August 30, 2019
Sponsor
PregLem SA
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1. Study Identification

Unique Protocol Identification Number
NCT01629563
Brief Title
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Acronym
PEARLIV
Official Title
A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PregLem SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
Detailed Description
The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulipristal acetate (PGL4001) 5mg
Arm Type
Experimental
Arm Description
All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
Arm Title
Ulipristal acetate (PGL4001) 10mg
Arm Type
Experimental
Arm Description
All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
Intervention Type
Drug
Intervention Name(s)
PGL4001 5 mg
Other Intervention Name(s)
Ulipristal Acetate, Esmya
Intervention Description
PGL4001 5 mg daily administration
Intervention Type
Drug
Intervention Name(s)
PGL4001 10 mg
Other Intervention Name(s)
Ulipristal Acetate
Intervention Description
PGL4001 10mg daily administration
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses
Description
Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.
Time Frame
18 months study duration per subject (4 3-month intermittent treatment courses)
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4
Description
Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.
Time Frame
After 18 months
Title
Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses
Description
Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.
Time Frame
After 18 months
Title
Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids
Description
For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses.
Time Frame
After 18 months
Title
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)
Description
Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses.
Time Frame
After 18 months
Title
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)
Description
Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses.
Time Frame
18 months
Title
Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)
Description
Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses.
Time Frame
After 18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be a pre-menopausal woman between 18 and 50 years inclusive. Have a Body Mass Index (BMI) ≥ 18 and ≤ 40. Have FSH levels ≤ 20 mIU/mL Have excessive uterine bleeding due to myoma. Have regular menstrual cycles Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter. If of childbearing potential the subject must be practicing a non-hormonal method of contraception. Exclusion Criteria: Has a history of or current uterine, cervical, ovarian or breast cancer. Has a history of or current endometrium atypical hyperplasia or adenocarcinoma. Has a known severe coagulation disorder. Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM). Has abnormal hepatic function at study entry. Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study. Has a current (within twelve months) problem with alcohol or drug abuse. Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Arrigada, MD
Organizational Affiliation
PregLem SA
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Centrum ambulantni gynekologie a primarni pece
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
FN Brno Gynekologicko - porodnická klinika
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Sanatorium SANUS
City
Hradec Kralove
ZIP/Postal Code
50002
Country
Czechia
Facility Name
Nemocnice Jihlava Gynekologicko - porodnicke oddeleni
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
G-CENTRUM Olomouc s.r.o.
City
Olomouc
ZIP/Postal Code
77200
Country
Czechia
Facility Name
FN Olomouc, Porodnicko-Gynekologicka klinika
City
Olomouc
ZIP/Postal Code
77220
Country
Czechia
Facility Name
Femina Sana, s.r.o.
City
Praha 3
ZIP/Postal Code
13000
Country
Czechia
Facility Name
Hôpital Bicêtre - APHP
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Bichat, Service de Gynécologie Obstétrique
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU Bretonneau Service de Gynécologie Obstétrique
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Private practice
City
Hamburg
ZIP/Postal Code
22159
Country
Germany
Facility Name
Private practice
City
Hamburg
ZIP/Postal Code
22359
Country
Germany
Facility Name
Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Frauenarztpraxis
City
Hessen
ZIP/Postal Code
60322
Country
Germany
Facility Name
Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Technische Universität München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Institution Robert Karoly Maganklinika
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo
City
Debrecen
ZIP/Postal Code
4024
Country
Hungary
Facility Name
Josa Andras Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Szuleszeti es Nogyogyaszati Osztaly
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Sandor Dent Bt.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Policlinico Universitario "Agostino Gemelli"
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Riga 1. hospital
City
Riga
ZIP/Postal Code
1001
Country
Latvia
Facility Name
Latvian Medical Marine Center
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Medical Company "ARS"
City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
Facility Name
Saules Family Medicine Center
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Facility Name
Family Medicine Centre"Seimos Gydytojas"
City
Vilnius
ZIP/Postal Code
01118
Country
Lithuania
Facility Name
Private Clinic "Maxmeda"
City
Vilnius
ZIP/Postal Code
03225
Country
Lithuania
Facility Name
Private Clinic "Kardiolita"
City
Vilnius
ZIP/Postal Code
05263
Country
Lithuania
Facility Name
Centrul Medical SANA SRL
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Quantum Medical Center SRL Obstetrica-Ginecologie
City
Bucuresti
ZIP/Postal Code
011426
Country
Romania
Facility Name
Fortis Medical Center SRL Obstetrica Ginecologie
City
Bucuresti
ZIP/Postal Code
012064
Country
Romania
Facility Name
Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie
City
Bucuresti
ZIP/Postal Code
020762
Country
Romania
Facility Name
Spitalul Clinic de Obstetrica
City
Iasi
ZIP/Postal Code
700398
Country
Romania
Facility Name
Kharkiv City Perinatal Center Gynaecological Department #1
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Municipal Institution "Maternity Hospital #1" City Center of family planning
City
Odessa
ZIP/Postal Code
65039
Country
Ukraine
Facility Name
Maternity Hospital#4 Department of Gynaecology
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
MRC Centre for Reproductive Health University of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4TJ
Country
United Kingdom
Facility Name
North Middlesex University Hospital NHS Trust
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Women's Health, Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR47UY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26477496
Citation
Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23.
Results Reference
derived
PubMed Identifier
25542821
Citation
Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24.
Results Reference
derived

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PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

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